Migraine HeadachesPhase 2NCT00109083
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
A Phase 2 study testing RWJ-333369 in people with Migraine Headaches, run by SK Life Science, Inc. at 25 sites in United States.
Trial summary
The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headaches
- What is being tested?
- RWJ-333369
- How many people
- 300 participants
- Where
- 25 sitesUnited States
- Study dates
- Mar 2002to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established history of migraines for at least 1 year;
- Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month;
- Migraines must have first started before age 50.
Who cannot join
- Most frequent headache type is not migraine;
- Failed 3 or more studies of effective migraine-preventing medications;
- Overuse of pain medications to treat migraines;
- Not willing to stop use of migraine-preventing medications;
- Significant serious concomitant diseases.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Study site
Alexandria, Virginia
Study site
Austin, Texas
Study site
Baton Rouge, Louisiana
Study site
Berkeley, California
Study site
Bismarck, North Dakota
Study site
Brockton, Massachusetts
Study site
Chaska, Minnesota
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Golden, Colorado
Study site
Greensboro, North Carolina
Study site
Houston, Texas
Study site
Lake Jackson, Texas
Study site
Little Rock, Arkansas
Study site
Miami, Florida
Study site
Middleton, Wisconsin
Study site
Mogadore, Ohio
Study site
Nashville, Tennessee
Study site
Northport, Alabama
Study site
Olympia, Washington
Study site
Phoenix, Arizona
Study site
Richardson, Texas
Study site
Springfield, Massachusetts
Study site
Springfield, Missouri
Study site
St. Petersburg, Florida
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine
The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.
- Conditions
- Migraine Headaches
- Being tested
- RWJ-333369
- Keywords
- Migraine, Headaches, Migraine headaches, Head pain
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RWJ-333369Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2005 (estimated)
- Study startMar 2002
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109083
- Sponsor's protocol ID
- 333369-MIG-2001
- Status last verified
- Aug 2012
- First submitted
- 22 Apr 2005
- Last updated
- 2 Aug 2012
- Results posted
- No
Publications
Cady RK, Mathew N, Diener HC, Hu P, Haas M, Novak GP; Study Group. Evaluation of carisbamate for the treatment of migraine in a randomized, double-blind trial. Headache. 2009 Feb;49(2):216-26. doi: 10.1111/j.1526-4610.2008.01326.x.
PubMed 19222595
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine
- ClinicalTrials.gov ID
- NCT00109083
- Acronym / sponsor ID
- 333369-MIG-2001
- Conditions
- Migraine Headaches
- Keywords
- Migraine, Headaches, Migraine headaches, Head pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 25 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established history of migraines for at least 1 year;
- Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month;
- Migraines must have first started before age 50.
Key exclusion criteria (5 listed)
- Most frequent headache type is not migraine;
- Failed 3 or more studies of effective migraine-preventing medications;
- Overuse of pain medications to treat migraines;
- Not willing to stop use of migraine-preventing medications;
- Significant serious concomitant diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RWJ-333369 | Drug | – |
Primary outcome
Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Derived from this study: PubMed 19222595Cady RK, Mathew N, Diener HC, Hu P, Haas M, Novak GP; Study Group. Evaluation of carisbamate for the treatment of migraine in a randomized, double-blind trial. Headache. 2009 Feb;49(2):216-26. doi: 10.1111/j.1526-4610.2008.01326.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RWJ-333369 in people with Migraine Headaches, run by SK Life Science, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00109083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.